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May 12, 2000

Testimony, Research on Vaccines and Mercury

To:   Vaccines & Related Biological Products           May 11, 2000
      Advisory Committee  Center for Biologics Evaluation & Research
      Food & Drug Administration
      Fr: Teresa Binstock Researcher in Developmental & Behavioral
Neuroanatomy
      Box 1788; Estes Park CO 80517

      My name is Teresa Binstock. I am diagnosed with Asperger's Syndrome, a
diagnostic cousin to high functioning autism.  From 1990 to 1998 I conducted
Independent Research while affiliated with the University of Colorado Health
Sciences Center and have published in molecular genetics and neuroanatomy.
Since 1996, my focus has been autism.
      Mr. Chairman, I express thanks and appreciation to you and the
committee for giving me this opportunity to speak regarding vaccinal
thimerosal and the possibility of its etiological significance in the
development of autism and related syndromes.
      Since mid-1997 I have perused immune-panels and other medical data
from autism-spectrum children, have been integrating their data with
information derived from medical articles, and then writing analyses for
physicians, researchers, and parents.  Since late 1999 I have been
participating with the authors of the mercury/autism paper initiated by
Sallie Bernard, Albert Enayati et al (1) as well as reading numerous mercury
neurotoxicity articles from medical journals.  This morning I shall outline
several points worthy of continued attention by this committee and similar
study groups within the FDA, CDC, and NIMH.
      Temporal association: coincidence or cause?
      Numerous anecdotes describe the temporal association between a
specific vaccination episode and the onset of regression into autism. Many
commentors would have us presume that this association is merely temporal.
However, immune panels and other medical data (eg, CBCs), medical histories,
and supporting medical literature suggest that, in many cases, the
association is causal and that the risks from injected ethylmercury  are
increased if the child is sick or has been recently sick. Furthermore, the
possibility of mercury-related causation is increased by a wide body of
literature describing known mechanisms of neurotoxicity.
      Is there a link between mercury-vaccinations and autism? Medical
literature documents organic mercury's effects upon microtubules, which
participate in neuronal function and in synaptogenesis (eg, 2-3). The timing
of infant and toddler thimerosal injections corresponds to major neuronal
development and synaptogenesis (the making of synapses) that occurs
postnatally in the human. This synaptogenesis occurs in regard to
eye-contact, smiling, early language, and other traits central to the
diagnostic criteria for autism (4).
      In many cases, the temporal associations among vaccination timings,
injected mercury, and autistic regressions are more likely to have been
causal because mercury's mechanisms of neurotoxicity are well documented and
provide basis for a precautionary hypothesis: thimerosal injections during
critical periods of postnatal central nervous system development are likely
to induce neurologic sequelae in some children. This leads to an important
question.
      Why are only some kids affected? Numerous studies have documented a
range of mercury responses, from not-affected to severely affected - in all
species thus far studied. This range of reactions derives from genetic
predispositions and/or from altered detoxification capabilities, which
themselves involve liver function and a small substance known as
glutathione. Many factors can affect liver function and glutathione
availability in infants and toddlers. For instance, a recent or
chronic-active infection can deplete glutathione. The factors which
predispose towards mercury neurotoxicity and their primary citations are
reviewed in Bernard et al (1), a copy of which has been made available to
the committee.  Similarly, thalidomide and Pink Disease provide human
examples wherein only some individual within exposed populations developed
adverse effects.
      I close by pointing out that the EPA's current "safe limit" is too
high. Please consider two points:
      First: Because vaccinations induce immune reactions that include
extended cytokines pulses (eg, interferon gamma), vaccinal mercury is more
dangerous than injected-mercury studies suggest because interferon gamma
increases permeability of tissues such as the blood-brain barrier and
gastrointestinal tract (5). Thus, when ethylmercury participates in a
vaccination response, more mercury is likely to enter the CNS.
      Second:  The hepatitis control report v4n21, 1999, offers a flawed
estimation for maximum safe levels for mercury, as set forth by the EPA (6).
The report mentions higher guidelines by the FDA and CDC and suggests that
the EPA level, which was lower than the other two, is unnecessarily low. In
other words, the rhetoric in the hepatitis control report suggests that a
higher level of mercury exposure ought be acceptable for infants and
toddlers. I disagree.
      The EPA's determination was based upon the amount of ingested mercury
needed to induce adverse neurologic sequelae in 10% of exposed fetuses. But
vaccinal ethylmercury is not first filtered by the maternal liver or
placenta, as was the mercury-poisoning incident used in the EPA
calculations. When ethylmercury is injected as part of a vaccination, the
infant brain is a far likelier target.
      Furthermore, since a 10% rate of neurologic sequelae is clearly not
acceptable, we might dwell upon the fact that to induce a 1% rate of
neurologic sequelae, the necessary level of mercury would be even lower than
the EPA's current estimate. And to achieve a point-two-five (.25) % rate of
neurologic sequelae -- which approximates the rate of autism during the
1990s, an even lower level of organic mercury would be required. For these
reasons, I believe that the EPA's guidelines for mercury toxicity are
artificially high and ought be lowered.
      My recommendation to this committee is as follows: for the reasons
outlined in this letter and in my letter to Congressman Burton, after this
day, May 11, 2000, no additional children ought be injected with
ethylmercury.
      Sincerely,
      Teresa Binstock,  Researcher in Developmental & Behavioral
Neuroanatomy
References
      1. Bernard S et al. Autism: a unique form of mercury poisoning.
http://www.canfoundation.org/sciwatch/invest.html (a condensed version has
been accepted for publication)
2. Sager PR, Matheson DW. Mechanisms of neurotoxicity related to selective
disruption of microtubules and intermediate filaments. Toxicology 49.479-92
1988.
3. Chapters 4, 18-22 in: Fundamental Neuroscience, MJ Zigmond, editor;
Academic Press, 1999.
4. Greenspan & Greenspan
5.  Binstock T. Mechanisms of vaccination sequelae: research document and
recommendation for Dan Burton, House Government Reform Committee, August 3,
1999. http://www.jorsm.com/~binstock/vacc-let.htm
6. Reference and discussion for CBER's  flawed calculation and flawed
conclusion.
Hg statistical calculations for Thimerosal: from a US govt analysis of
thimerosal:
http://www.hepatitiscontrolreport.com/vol/v4n21.html
      "EPA's guideline (called the EPA reference dose, or RfD)
is truly cautious. It is based on a single episode of methylmercury
poisoning in Iraq in which 81 children were exposed to high levels
of mercury in utero. EPA calculated the RfD by determining the
dose that produced a 10% prevalence of adverse neurological
effects in the affected children, such as late walking, late talking,
and abnormal neurological scores. The agency then placed a 95%
confidence interval around this dose and divided the lower bound
of the interval by an "uncertainty factor" of 10 to arrive at the RfD."
      Comment: If the RfD was generated by considering a 10% rate of
adverse neurologic effects, what would be the RfD if the acceptable
rate had been "the amount of organic Hg needed so as to induce
adverse effects in 1%?  In .5%?  In .25%
      As the adverse-effects percentage declines, the total amount needed to
induce those effects also declines. At the 1% rate, the RfD's fudge
factor (ie "Uncertainty Factor") is nullified.
      For what family is a neurologically impaired child acceptable?
One in 100 kids (~1% RfD "safety" level)?
One in 200 kids (~.5% RfD "safety" level)?
One in 400 kids (~.25% RfD "safety" level)?
      At what RfD total Hg do we begin to see incidence rates
(of adverse neurologic effects) that approximate autism-prevalence
rates? To whom are these rates "acceptable"?
      What local, county, state, or federal governmental agency will happily
fund any and all extra services needed by families with a child whose
neurologic deficits were within government-approved limits?

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Iatrogenic Exposure To Mercury After Hepatitis B Vaccination In Preterm
Infants

      [Journal of Pediatrics - Abstract May 2000 . Volume 136 . Number 5
Clinical and Laboratory Observations.  Thanks to snelgrove.]

Iatrogenic exposure to mercury after hepatitis B vaccination in preterm
infants http://www1.mosby.com/scripts/om.dll/serve?action=searchDB&searchDBfor=art&artype=abs&id=a105133&nav=abs
     Gregory V. Stajich, PharmD [MEDLINE LOOKUP]
     Gaylord P. Lopez, PharmD, ABAT [MEDLINE LOOKUP]
     Sokei W. Harry, MBBS, MPH [MEDLINE LOOKUP]
     William R. Sexson, MD [MEDLINE LOOKUP]

      Thimerosal, a derivative of mercury, is used as a preservative in
hepatitis B vaccines. We measured total mercury levels before and after the
administration of this vaccine in 15 preterm and 5 term infants. Comparison
of pre- and post-vaccination mercury levels showed a significant increase in
both preterm and term infants after vaccination.
      Additionally, post-vaccination mercury levels were significantly
higher in preterm infants as compared with term infants. Because mercury is
known to be a potential neurotoxin to infants, further study of its
pharmacodynamics is warranted. (J Pediatr 2000;136;679-81)

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